News from the Research Administration and Compliance Office at the University of California, Berkeley

January 25, 2018

Important NIH Application Changes Effective January 25, 2018

Three important changes affect National Institutes of Health applications as of today, January 25, 2018:

For NIH applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. The requirement does not apply to career development, research training or fellowship awards.

Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

Also effective for NIH due dates on or after January 25, 2018, NIH will require all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed and designated for clinical trials.